FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS.
Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.
For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms and as an adjunctive in systemic sulfonamide therapy of trachoma:
ISOPTO CETAMIDE® (sulfacetamide sodium ophthalmic solution, USP) 15% is a sterile topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:
Chemical name: N-Sulfanilylacetamide monosodium salt monohydrate
Each mL contains: Active: Sulfacetamide sodium 150 mg (15%). Preservatives: Methylparaben 0.05%, Propylparaben 0.01%. Vehicle: Hydroxypropyl Methylcellulose 2910 0.5%. Inactives: Sodium Thiosulfate, Dibasic Sodium Phosphate and/or Monobasic Sodium Phosphate (to adjust pH), Purified Water. pH range between 7.0 and 7.8. DM-02
For conjunctivitis and other superficial ocular infections
Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
For Trachoma
Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.
For conjunctivitis and other superficial ocular infections:
Solution: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
Ointment: Apply a small amount (approximately one-half inch ribbon) into the conjunctival sac(s) of the affected eye(s) every three to four hours and at bedtime. Dosages may be tapered by increasing the time interval between doses as the condition responds. The ointment may be used as adjunct to the solution. The usual duration of treatment is seven to ten days.
How to apply CETAMIDE™ Ointment:
Tilt your head back.
Place a finger on your cheek just under your eye and gently pull down until a “V” pocket is formed between your eyeball and your lower lid.
Place a small amount (about ½ inch) of CETAMIDE™ Ointment in the “V” pocket. Do not let the tip of the tube touch your eye.
Look downward before closing your eye.
For Trachoma:
Solution: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.